A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5

NCT05585567 | Unknown Early Phase 1

• 1 other identifier: V-01-B5- Booster-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (5)

• Adverse Event (AE)

  Observe the AEs occurs at different time point after vaccination

  30 minutes after vaccination

• AEs

  Observe the AEs occurs at different time point after vaccination

  0-7 days after vaccination

• AEs

  Observe the AEs occurs at different time point after vaccination

  0-28 days after vaccination

• Serious adverse event (SAE) and adverse event of special interest (AESI)

  Observe the SAE and AESI after vaccination

  Within 12 months after vaccination

• Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5

  Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)

  28 days after vaccination

Secondary Outcomes (4)

• Neutralizing antibody GMT of other SARS-CoV-2 variants

  Until 12 months after vaccination

• Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)

  Until 12 months after vaccination

• Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)

  Until 12 months after vaccination

• Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level

  Until 12 months after vaccination

Study Arms (3)

V-01/V-01-B5 group

EXPERIMENTAL

One dose of V-01/V-01-B5

Biological: V-01/V-01-B5

V-01-351/V-01-B5 group

EXPERIMENTAL

One dose of V-01-351/V-01-B5

Biological: V-01-351/V-01-B5

V-01 group

EXPERIMENTAL

One dose of V-01

Biological: V-01

Interventions

V-01/V-01-B5 BIOLOGICAL

Contains 10μg of V-01 and 10μg of V-01-B5

V-01/V-01-B5 group

V-01-351/V-01-B5 BIOLOGICAL

Contains 10μg of V-01-351 and 10μg of V-01-B5

V-01-351/V-01-B5 group

V-01 BIOLOGICAL

Contains 10μg of V-01

V-01 group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 -59 years old at time of consent, male or female;
• Normal body temperature;
• Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months;
• Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;
• Be able and willing to complete the study during the entire study and follow-up period;
• Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.

You may not qualify if:

• Serious chronic diseases or uncontrolled diseases;
• Uncontrolled neurological disorders, epilepsy;
• Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;
• Patients with congenital or acquired immunodeficiency;
• History of severe allergy or be allergic to any components of the test vaccines;
• History of hereditary hemorrhagic tendency or coagulation dysfunction;
• Patients with malignant tumors and other patients have a life expectancy less than 1 year;
• Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol;
• History of previous COVID-19 infection;
• Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study;
• Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials;
• Those considered by the investigator as inappropriate to participate in the study.

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

Study Sites (1)

Shaoguan Hospital of Chinese Medicine

Shaoguan, Guangdong, 512000, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 19, 2022
• Study Start: September 16, 2022
• Primary Completion: October 14, 2022
• Study Completion: September 11, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-10

Locations

CN (1)